FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 1043000
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33641
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 19, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4470 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other | THE DEVICE 1291/106252 WAS IMPLANTED 30-MAR-2005| THE DEVICE 4018/BIR150 WAS IMPLANTED 24-MAY-2003 |